Diabetic Limb Arteriosclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: (1) Meets the diagnostic criteria for type 2 diabetes. (2) Belongs to the II stage of patients diagnosed with DAO according to Western medical diagnostic criteria. (3) Meets the diagnostic criteria for blood stasis syndrome in traditional Chinese medicine (TCM) differential diagnosis. (4) Aged between 40 and 70 years old. (5) Has signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Lower extremity pain, numbness, coldness, etc., caused by vascular or non-vascular diseases. (2) Patients with severe primary diseases involving organs (heart, brain, liver, kidney), hematopoietic system, endocrine system, or mental health issues. (3) Individuals with an allergic constitution or a history of allergy to any components of the study drug. (4) Women who are pregnant, breastfeeding, or intending to become pregnant. (5) Patients currently using Chinese or Western medicine for this condition or participating in other drug trials within the past two weeks. (6) Patients with significantin the TCM syndrome differentiation (blood stasis syndrome). (7) Patients with uncontrollable bleeding disorders, coagulation disorders, a tendency to bleed, or active bleeding within the past two weeks. (8) Patients who have undergone major surgery or significant trauma within the past two months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Cholesterol;Triglycerides;Low-Density Lipoprotein ;High-Density Lipoprotein;Tumor Necrosis Facto;Interleukin-1 (IL-1);Interleukin-6 (IL-6);Ankle-Brachial Index (ABI);Toe-Brachial Index (TBI);Superoxide Dismutase (SOD);Malondialdehyde (MDA);Total Antioxidant Capacity (TAC);Nitric Oxide (NO);Endothelin-1 (ET-1); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain Level in the Affected Limb;Numbness Level in the Affected Limb;Skin Temperature of the Affected Limb;Skin Color of the Affected Limb;Claudication Distance; | — |
Countries
China
Contacts
Hebei Provincial Traditional Chinese Medicine Hospital